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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Directory / Orthopedics & Spine

Orthopedics & Spine

ArthroTAK

Orlando, FL · Unknown · 510(k) cleared

Orlando, Florida orthopedic startup making a sutureless PEEK tendon anchor for soft tissue to bone fixation. Its first 510(k), K252635, was cleared in May 2026 for biceps tenodesis, and a second clearance announced in September 2026 added lateral extra-articular tenodesis in the knee.

FDA DECISIONS ON FILE

1 IN THE TRACKER

Decision	Number	Device	Applicant	Panel	Code
May 1, 26	K252635510(k)	ArthroTAK Tendon Anchor Kit	ArthroTAK, LLC	Orthopedic	MBI

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ArthroTAK

FDA DECISIONS ON FILE

COVERAGE